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A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients

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Trial Profile

A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Jun 2023

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At a glance

  • Drugs Dalcinonacog alfa (Primary) ; Dalcinonacog alfa (Primary) ; Nonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors ISU Abxis

    • Most Recent Events

    • 12 Jun 2023 Results supporting dosing regimen selection in adults and perform first in paediatric dose extrapolations using a model based pharmacokinetic (PK) approach of population PK model built using adult data from NCT03186677and NCT03995784, published in the Advances in Therapy
    • 04 Feb 2021 Results published in the Journal of Thrombosis and Haemostasis
    • 07 Mar 2019 Status changed from recruiting to completed, as reported in a Catalyst Biosciences media release.
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